Orange Book product · Brand (NDA)
REGLAN
METOCLOPRAMIDE HYDROCHLORIDE
At a glance
May 28, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 1987
39 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017862
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2020GIMOTIBrand (NDA)
NDA 209388 · QOL MEDCL
- 2009METOZOLV ODTBrand (NDA)
NDA 022246 · SALIX PHARMS
- 2005REGLAN ODTBrand (NDA)
NDA 021793 · MEDA PHARMS
- 1983REGLANBrand (NDA)
NDA 018821 · ROBINS AH
- 2024METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 072215 · AIPING PHARM INC
- 2014METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 202191 · NOVEL LABS INC
- 2013METOCLOPRAMIDEGeneric (ANDA)
ANDA 204756 · AVET LIFESCIENCES
- 2013METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 091392 · FRESENIUS KABI USA
- 2008METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078807 · IPCA LABS LTD
- 2007METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078374 · NORTHSTAR HLTHCARE
- 2001METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 075051 · VISTAPHARM LLC
- 1997METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 074703 · PHARMOBEDIENT CNSLTG
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
